Which document outlines how a clinical trial is to be conducted?

The document that outlines how a clinical trial is to be conducted is known as a protocol. This comprehensive plan provides detailed information about the objectives, design, methodology, statistical considerations, and organization of the trial. It serves several critical purposes: it ensures the integrity of the trial, facilitates the collection of data to meet regulatory requirements, and aids in the ethical treatment of participants by clearly defining procedures and processes.

The protocol includes specifics on how patients will be recruited, the treatment intervention details, the schedule of assessments, and any safety monitoring requirements. All stakeholders involved—researchers, regulatory agencies, and ethics committees—rely on the protocol to ensure adherence to good clinical practice throughout the trial.

Other terms like methodology, guidelines, and framework might pertain to aspects of research or clinical practice, but they do not specifically define the detailed procedural document that a clinical trial protocol represents. Methodology can refer to the underlying principles guiding the research design but does not provide the structured approach like a protocol. Guidelines generally offer broad recommendations rather than detailed instructions specific to a single trial. A framework could indicate a conceptual structure but lacks the specificity of how a trial will be executed.